{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Oulu",
      "advisory_committee_description": "Immunology",
      "address_1": "Kiviharjuntie 11 4 B",
      "address_2": "",
      "statement_or_summary": "Statement",
      "product_code": "DCK",
      "openfda": {
        "registration_number": [
          "8020316",
          "9614373",
          "3006198300",
          "1000403749",
          "2432235",
          "9680746",
          "1181055",
          "3012471076",
          "3017505309",
          "3005146313",
          "2025099",
          "3005360469",
          "1827821",
          "2245285",
          "3022178699",
          "9613069",
          "2029372",
          "3005984081",
          "3012963943",
          "3002809144",
          "1220972",
          "2050012",
          "3000148879",
          "3019906",
          "2431980",
          "2050010",
          "2032900",
          "2030861",
          "3002642396",
          "2250051",
          "3000308930",
          "3005333358",
          "1832216",
          "3004493545",
          "1319681",
          "9610126",
          "1319809",
          "3002800697",
          "2084025",
          "3014607865",
          "3011989923",
          "3003871639",
          "1319808",
          "3026565854",
          "9681753",
          "9610102",
          "2085064"
        ],
        "fei_number": [
          "3006198300",
          "1000403749",
          "3000215862",
          "1000305840",
          "2432235",
          "3004445302",
          "3000303338",
          "1181055",
          "3012471076",
          "3017505309",
          "3005146313",
          "1827821",
          "2245285",
          "3022178699",
          "1000135102",
          "3005984081",
          "3012963943",
          "3002809144",
          "1220972",
          "3002806809",
          "2050012",
          "3007981058",
          "3000148879",
          "3019906",
          "2431980",
          "2050010",
          "1000306617",
          "3002642396",
          "2250051",
          "3000308930",
          "3005333358",
          "3004493545",
          "1000305841",
          "3002800697",
          "2084025",
          "3002806559",
          "3014607865",
          "3003045237",
          "3011989923",
          "3003871639",
          "3005670738",
          "3026565854",
          "3002807786",
          "3002808340",
          "1832216",
          "1000206808",
          "1000136573"
        ],
        "device_name": "C-Reactive Protein, Antigen, Antiserum, And Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5270",
        "device_class": "2"
      },
      "zip_code": "90220",
      "applicant": "Orion Diagnostica, OY",
      "decision_date": "2016-03-10",
      "decision_code": "SESE",
      "country_code": "FI",
      "device_name": "QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument",
      "advisory_committee": "IM",
      "contact": "ANJA  KONTIO",
      "expedited_review_flag": "",
      "k_number": "K142993",
      "state": "",
      "date_received": "2014-10-16",
      "review_advisory_committee": "IM",
      "postal_code": "90220",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}